Leg UlcerPhase 1NCT02993809
Autologous Transplantation of BM-ECs With Platelet-Rich Plasma Extract for the Treatment of Critical Limb Ischemia
A Phase 1 study testing BM-ECs and PRPE and BM-ECs in people with Leg Ulcer and Diabetic Foot, run by South China Research Center for Stem Cell and Regenerative Medicine.
Trial summary
The intent of this clinical study is to evaluate the safety of the injection composed of autologous bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE) for the treatment of critical limb ischemia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Leg Ulcer, Diabetic Foot, Gangrene
- What is being tested?
- BM-ECs and PRPE and BM-ECs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Limb ischemia patients(e.g. arteriosclerosis obliterans,diabetic critical limb ischemia, thromboangitis obliterans)
- 18 Years to 80 Years (Adult, Senior);
- Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ;
- Patient meets at least one of the following diagnostic criteria for the index limb:
- ABI<0.7mmHg
- TcpO2 <40 mm Hg
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- Or, nonhealing ulcer due to local arterial compromise with no opportunity for revascularization;
- Have no improvement after conservative treatment and are not suitable for surgical bypass surgery because no outflow tract of diseased vessel can be found by imaging;
- Despite having good outflow artery, but the elderly and frail patients can also not tolerate revascularization or interventional surgery;
- Unlikelihood of major amputation of the leg during the next 12 months;
- Expected life span more than 2 years.
Who cannot join
- Pregnant or lactating;
- Diabetics with poorly controlled blood glucose levels (defined as HbA1c>7% and/or proliferative retinopathy);
- Patients with decompensated cardiac, renal or liver disease;
- Patients with confirmed malignant tumor;
- Subjects are with serious heart, liver, kidney and lung failure or under poor general condition that are inability to undergo bone marrow harvesting and transplantation;
- Known or suspected disease of the immune system or osteomyelitis;
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- Inability to sign informed consent form and to comply with the schedule of the study;
- There has reason to suspect that the patient is forced to join the study;
- Any other condition, in the opinion of the investigator, would render the patient unsuitable for the study.
Trial locations and contacts
No sites are listed yet.
About this study
The intent of this clinical study is to evaluate the safety of the injection composed of autologous bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE) for the treatment of critical limb ischemia.
- Conditions
- Leg Ulcer, Diabetic Foot, Gangrene, Peripheral Vascular Disease, Ischemia
- Being tested
- BM-ECs and PRPE, BM-ECs
- Medical subject headings
- Leg Ulcer, Diabetic Foot, Gangrene, Peripheral Vascular Diseases, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BM-ECs and PRPEBiological
BM-ECsBiological
| Study group | Role | What they receive |
|---|---|---|
| BM-ECs and PRPE | Experimental | Multipoint of intramuscular injections into ischemic limbs.Injections composed of bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE). Receives: Biological: BM-ECs and PRPE |
| BM-ECs | Active comparator | Intramuscular injection of bone marrow derived endothelial cells only. Receives: Biological: BM-ECs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival without major amputation
Measured: 6 months after implantation
Secondary outcomes (7)
Perfusion rate in treated tissue by measure of ankle-brachial index (ABI)
Measured: Within 6 months after implantation
Perfusion rate in treated tissue by transcutaneous PO2 (TcPO2)
Measured: Within 6 months after implantation
Perfusion rate in treated tissue by digital subtraction angiography (DSA)
Measured: Within 6 months after implantation
wound size
Measured: Within 6 months after implantation
wound stage
Measured: Within 6 months after implantation
Pain intensity
Pain intensity using Visual Analogue Scale
Measured: Within 6 months after implantation
Thermography
Measured: Within 6 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startMar 2018
- Primary completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South China Research Center for Stem Cell and Regenerative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993809
- Sponsor's protocol ID
- BMEC-PRPE
- Status last verified
- Sep 2016
- First submitted
- 23 Nov 2016
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Transplantation of BM-ECs With Platelet-Rich Plasma Extract for the Treatment of Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT02993809
- Acronym / sponsor ID
- BMEC-PRPE
- Conditions
- Leg Ulcer, Diabetic Foot, Gangrene, Peripheral Vascular Disease, Ischemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- South China Research Center for Stem Cell and Regenerative MedicineUniversity, hospital or other
- Study start
- Mar 2018
- Primary completion
- Dec 2019 (estimated)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The intent of this clinical study is to evaluate the safety of the injection composed of autologous bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE) for the treatment of critical limb ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BM-ECs and PRPE | Experimental | Biological: BM-ECs and PRPEMultipoint of intramuscular injections into ischemic limbs.Injections composed of bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE). |
| BM-ECs | Active comparator | Biological: BM-ECsIntramuscular injection of bone marrow derived endothelial cells only. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Limb ischemia patients(e.g. arteriosclerosis obliterans,diabetic critical limb ischemia, thromboangitis obliterans)
- 18 Years to 80 Years (Adult, Senior);
- Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ;
- Patient meets at least one of the following diagnostic criteria for the index limb:
- Have no improvement after conservative treatment and are not suitable for surgical bypass surgery because no outflow tract of diseased vessel can be found by imaging;
Key exclusion criteria (9 listed)
- Pregnant or lactating;
- Diabetics with poorly controlled blood glucose levels (defined as HbA1c>7% and/or proliferative retinopathy);
- Patients with decompensated cardiac, renal or liver disease;
- Patients with confirmed malignant tumor;
- Subjects are with serious heart, liver, kidney and lung failure or under poor general condition that are inability to undergo bone marrow harvesting and transplantation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BM-ECs and PRPE | Biological | BM-ECs and PRPE |
| BM-ECs | Biological | BM-ECs |
Primary outcome
Survival without major amputation
Time frame: 6 months after implantation
7 secondary outcomes
Perfusion rate in treated tissue by measure of ankle-brachial index (ABI)
Time frame: Within 6 months after implantation
Perfusion rate in treated tissue by transcutaneous PO2 (TcPO2)
Time frame: Within 6 months after implantation
Perfusion rate in treated tissue by digital subtraction angiography (DSA)
Time frame: Within 6 months after implantation
wound size
Time frame: Within 6 months after implantation
wound stage
Time frame: Within 6 months after implantation
Pain intensity
Time frame: Within 6 months after implantation
Thermography
Time frame: Within 6 months after implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BM-ECs and PRPE and BM-ECs in people with Leg Ulcer and Diabetic Foot, run by South China Research Center for Stem Cell and Regenerative Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuetao Pei, M.D., Ph.D (8610-68164807, AMMS0906@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival without major amputation (time frame: 6 months after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2016.